+31 31 65 28 275info@vongahlen.nl

Validation & Qualification IQ-OQ

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Von Gahlen offers different stages of verification with the installation of products, whether it consists of a single hot cell or a complete laboratory setup. Our products are offered standard with a Design Qualification (DQ) stage and a Factory Acceptance Test (FAT). The DQ is an agreement between the customer and Von Gahlen concerning the proposed lay out of the product by confirming that the equipment meets the written acquisition specification. Options and special modifications will be made available to view in the total 3D lay-out drawing. After the DQ stage is successfully completed manufacturing will start.

After manufacturing of the products, the customer will be invited for the FAT at our main factory in Zevenaar, the Netherlands. This test is conducted to determine if the requirements of the specifications are met.

Von Gahlen will separately offer the validations tests Installation Qualification (IQ) and Operational Qualification (OQ) including all documentation.

These tests will be performed on site and will include any or all of the products installed.

All essential tests will be performed based on the delivered Installation Qualification and Operational Qualification documentation. Von Gahlen will execute these tests and will provide all necessary equipment (ie particle counter).  

Please contact the Von Gahlen Sales Team. We would be pleased to offer you a complete solution regarding the qualification and verification of your products.

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